Implementation of Machine Learning and Hemodynamic Profiles Based Clinical Decision Support Syste… (NCT06828692) | Clinical Trial Compass
RecruitingNot Applicable
Implementation of Machine Learning and Hemodynamic Profiles Based Clinical Decision Support Systems for Personalized Guideline Accordant Antihypertensive Regimens in Primary Care: a Pragmatic Cluster Randomized Controlled Trial
China2,160 participantsStarted 2025-05-26
Plain-language summary
This trial is a prospective, multicenter, single-blind, three-arm parallel-group, cluster randomized controlled trial assessing the effectiveness and safety of two types of CDSS in primary care settings in China. Primary care sites are randomized to one of the intervention arms or the control arm (1:1:1 ratio) using computer-generated random numbers stratified by region and administrative categories of the primary healthcare institutions (including community health centers, community health stations, and township health centers). A total of 51 primary care sites are randomized to three groups, with 17 sites assigned to group A (use a CDSS based on clinical guidelines and machine learning), 17 sites to group B (use a CDSS based on guidelines, hemodynamic parameters and ML), and the remaining 17 sites to the control group.
Who can participate
Age range35 Years – 79 Years
SexALL
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Inclusion criteria
✓. 35 ≤ Age \< 80 years.
✓. Regularly attend the clinic for hypertension treatment during the study period, without plans of traveling during the study period.
✓. Diagnosed with hypertension, with SBP ≥140mmHg at screening.
✓. Currently taking 0 or 2 classes of antihypertensive medications (A/C/D), with or without concurrent use of class B.
✓. Willing to participate in the trial and capable of providing written informed consent.